Label: MOISTURIZING DANDRUFF 1% PYRITHIONE ZINC- pyrithione zinc shampoo

  • NDC Code(s): 54111-169-50
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 6, 2023

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredient ........... Pyrithione Zinc 1%

  • PURPOSE

    Purpose  ......... Anti-Dandruff

  • INDICATIONS & USAGE

    Uses: Controls skin itching, and redness due to dandruff.

  • DOSAGE & ADMINISTRATION

    Directions: Get hair wet and coat evenly with shampoo from scalp to ends.
    Gently massage into scalp for at least 1 minute to fully exfoliate and moisturize it.
    Rinse completely clean. Repeat as desired. For best results use at least twice a week
    or as directed by a doctor.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. If contact occurs, rinse
    Eyes thoroughly with water. If condition worsens or does not improve after regular use
    of this product as directed, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact or contact a Poison Control Center
    right away.

  • INACTIVE INGREDIENT

    INGREDIENTS: WATER/AQUA/EAU, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL HYDROXYSULTAINE, ACRYLATES COPOLYMER, FRANGRANCE/PARFUM, PROPANEDIOL, PANTHENOL, SALICYLIC ACID, POLYQUATERNIUM-53, PHENOXYETHANOL, COCAMIDOPROPYLAMINE OXIDE, POLYQUATERNIUM-6, CAPRYLYL GLYCOL, SODIUM BENZOATE, PEG-120 METHYL GLUCOSE DIOLEATE, RAPHANUS SATIVUS (RADISH) ROOT EXTRACT, PROPYLENE GLYCOL, SODIUM HYDROXIDE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, SODIUM POLYNAPHTHALENESULFONATE, SODIUM CHLORIDE, XANTHAN GUM, HYDROXYCITRONELLAL, AMYL CINNAMAL

  • Geologie Package

    Geologie

    CUSTOM CONTROL HAIRCARE

    Moisturizing

    Dandruff Shampoo

    1% Zinc Pyrithione

    236 ml 8 fl oz

    Geologie.com Made in USA of imported materials
    Distributed by Geologie New York, NY 10163

    169-50 Shmpoo

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  • INGREDIENTS AND APPEARANCE
    MOISTURIZING DANDRUFF  1% PYRITHIONE ZINC
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    LUVISET 360 (UNII: 05BG6GY6YK)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    POLYQUATERNIUM-53 (UNII: FLN8G45C73)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    RADISH (UNII: EM5RP35463)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM METHYLENEBISNAPHTHALENESULFONATE (UNII: YD6DS3JR98)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-169-50236 mL in 1 POUCH; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/01/2023
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Geologie (081158549)
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